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Objectives/Hypothesis
To evaluate the performance and safety of the newly developed Laryngeal Pacemaker System (LP System) for the treatment of bilateral vocal fold paralysis (BVFP).
The Laryngoscope
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Laryngology
Laryngeal pacing via an implantable stimulator for the rehabilitation of subjects suffering from bilateral vocal fold paralysis: A prospective first-in-human study
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The authors received travel grants to present results of this study at scientific conferences. MED-EL financially supported part of the preclinical research performed by SRH Wald-Klinikum on the laryngeal pacing. MED-EL Medical Electronics, Innsbruck, Austria, sponsored the clinical study. The first author received research grants from German Ministry of Education (01EZ0335) and the SRH foundation to conduct the laryngeal pacing project. Andreas H. Mueller, MD, wrote the first draft of the manuscript. No honorarium, grant, or other form of payment was given to anyone to produce the article. Each author listed on the article has seen and approved the submission of this version of the article and takes full responsibility for the article.
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The authors have no other funding, financial relationships, or conflicts of interest to disclose.
Abstract
Study Design
Feasibility, first-in-human, single-arm, open-label, prospective, multicenter study with a group sequential design and a 6-month follow-up period.
Methods
Nine symptomatic BVFP subjects were implanted unilaterally with the LP System. Pre- and 6-month postimplantation evaluations consisted of the 6-Minute Walk Test (6MWT), the Peak Expiratory and Inspiratory Flow (PEF and PIF) evaluation, the PEF meter analysis, the 36-Item Short Form Health Survey (SF-36), the Glasgow Benefit Inventory (GBI), the 12-Item Voice Handicap Index (VHI-12), and the Fiberoptic Endoscopic Evaluation of Swallowing. The safety profile of the LP System was continuously monitored.
Results
The LP System implantation was achieved in 8/9 cases. Seven of the nine subjects completed the study. Absolute PEF and PIF values improved significantly 6 months postimplantation (P < .05). 6MWT results showed a non–statistically significant improvement (P = .09). The mental component of the SF-36 showed a significant improvement (P = .043), whereas the other SF-36 components, the GBI, and the VHI-12 results did not changed significantly. The LP System did not affect the voice and swallowing quality and maintained a reliable safety profile for the duration of the study.
Conclusions
This feasibility study showed that the LP System has the potential to become an effective and safe treatment for BVFP subjects without compromising the patients' voice.
Level of Evidence
2b Laryngoscope, 126:1810–1816, 2016